The court case I have chosen to examine is David Franklin versus Parke-Davis, which was a landmark lawsuit that ultimately ended up setting the precedence for future lawsuits against pharmaceutical companies for off-label promotion using the False Claims Act set forth in the Food, Drug and Cosmetic Act of 1938 (FDCA). David Franklin was PHD level scientist who was employed by Parke-Davis as a medical liaison in 1996. The parent company for Parke-Davis at the time was the Warner-Lambert Company in which Park-Davis was responsible for the pharmaceutical products division that included the manufacturing, marketing and research and development for novel medications and therapies. During Franklin’s short tenure at Parke-Davis, he claimed that …show more content…
his training consisted of using techniques that were blatantly illegal and his job was primarily to do and say anything to get doctors to prescribe the drug Neurontin. The drug Neurontin is a medication manufactured by Parke-Davis and was approved by the FDA December 30, 1993 for the following indications; post herpetic neuralgia, epilepsy and moderate-to-severe restless legs syndrome (RLS) . It is an anti-epileptic and anticonvulsant medication that is sold under the generic name Gabapentin1. This medication, however, has a long list of off-label and investigational uses that, in accordance with the FDCA, cannot be marketed to physicians or health care providers by the manufacturing company. Marketing and advertising must remain confined to FDA approved indications; off-label marketing or promotion is strictly prohibited. During Franklin’s time at Parke-Davis, the company executives wanted him to use his doctorate degree to earn the trust of doctors, who were used to dealing with marketing and sales people selling the medications and not scientists. Once gaining the physicians trust, he was encouraged to close the deal by any means necessary. This usually meant convincing physicians to prescribe the medication Neurontin for off-label uses while making it appear to the physician like he was the only one not using it for those indications. In addition, Franklin claims that he was instructed to make exaggerated or false claims concerning the safety and efficacy of Park-Davis drugs for off-label uses . This also included at times recommending much more than the FDA approved maximum dosage. The physicians that Franklin and his colleagues were successful in convincing received kickbacks that included expensive dinners, resort trips and cash as well as tickets to the Olympics. Other examples cited by Franklin allege that fraudulent journal articles reporting favorable results for off-label indications were signed off on by compensated physicians. David Franklin eventually quit the company and filed a nine-count qui tam action under seal on August 13, 1996, which remained sealed for several years while the United States decided whether or not to intervene2.
The term qui tam is used as a writ in which a private citizen who assists in the prosecution is entitled to receive a portion of any monetary penalties levied . This also allows a private individual, termed “whistle-blower”, to use the False Claims Act (FCA) to present fraud perpetrated against the federal government3. The purpose of the lawsuit entered by Franklin would ultimately seek retribution to the United States for the millions of dollars spent by Medicaid for the medication Neurontin that was prescribed by physicians under fraudulent …show more content…
pretenses. The lawsuit brought on Parke-Davis was a landmark case in that there had been no prior precedent holding pharmaceutical companies accountable for fraudulently reimbursed Medicaid claims. The use of the FCA was a unique strategy used by Franklin’s lawyer Thomas Greene which would categorize David Franklin essential as a whistle-blower. The part that Franklin played in the lawsuit that characterized him as a whistle-blower also entitled him to a portion of the proceeds, if any, paid by Parke-Davis in civil damages. The sealed case remained unopened for three years until finally the Department of Justice decided that it would not intervene and the case was then able to proceed. The federal judge presiding over the case, Patti B. Saris, ultimately found that it could, in fact, be proven that off-labeling marketing tactics caused invalid reimbursement through Medicaid. The parent company Warner Lambert and the newly acquired Pfizer agreed to pay $430 million to resolve criminal and civil related to the off-label marketing of Neurontin, of which, David Franklin received 29.5% of the settlement . This case was historic to the pharmaceutical industry for several reasons.
Firstly, this case marked the inaugural lawsuit brought against a pharmaceutical company for using off-label marketing tactics utilizing the False Claims Act as the legal framework. The use of the FCA would pave the way for a multitude of future lawsuits involving off-labeling techniques used by large pharmaceutical companies along with citing kickbacks paid to physicians (quid pro quo) for prescribing the medication to patients, with special incentives given to physicians writing the most prescriptions. The second reason it was important is because up to that date, it was the largest settlement awarded as well as one of the highest awarded to a private individual for his role in exposing the fraud perpetrated by his employer. The whistle-blower categorization would now be able to provide private citizens with major portions of large settlements, thus providing monetary incentive for employees to come forward with information that could expose fraudulent business practices perpetrated by large corporations. This ruling also made a clear precedent that the FDCA of 1938 could be used in conjunction with the Medicaid and Medicare fraud abuse laws to levy civil and criminal offenses against pharmaceuticals companies for engaging in unethical marketing practices using indications for a medication not approved by the FDA. One of the biggest atrocities perpetrated in this case, which cannot be
overstated, is the total disregard for the patients being prescribed this medication by physicians sold on a bill of fraudulent claims, for which the medication had no viable claim to.
In the Lexington, Kentucky a drug operation occurred at an apartment complex. Police officers of Lexington, Kentucky followed a suspected drug dealer into an apartment complex. The officers smelled marijuana outside the door of one of the apartments, as they knocked loudly the officers announced their presence. There were noises coming from the inside of the apartment; the officers believed that the noises were as the sound of destroying evidence. The officers stated that they were about to enter the apartment and kicked the apartment door in in order to save the save any evidence from being destroyed. Once the officer enters the apartment; there the respondent and others were found. The officers took the respondent and the other individuals that were in the apartment into custody. The King and the
Facts: On October 3, 1974, Memphis Police Officers Hymon and Wright were dispatched to answer a “prowler inside call.” When the police arrived at the scene, a neighbor gestured to the house where she had heard glass breaking and that someone was breaking into the house. While one of the officer radioed that they were on the scene, the other officer went to the rear of the house hearing a door slam and saw someone run across the backyard. The suspect, Edward Garner stopped at a 6-feet-high fence at the edge of the yard and proceeded to climb the fence as the police officer called out “police, halt.” The police officer figured that if Garner made it over the fence he would get away and also “figured” that Garner was unarmed. Officer Hymon then shot him, hitting him in the back of the head. In using deadly force to prevent the escape of Garner, Hymon used the argument that actions were made under the authority of the Tennessee statute and pursuant to Police Department policy. Although the department’s policy was slightly more restrictive than the statute it still allowed the use of deadly force in cases of burglary. Garner’s fathers’ argument was made that his son was shot unconstitutionally because he was captured and shot possessing ten dollars that he had stolen and being unarmed showing no threat of danger to the officer. The incident was then reviewed by the Memphis Police Firearm’s Revie...
and fair one. Many believe it to be the first anti- trust decision in U.S.
The People vs. Hall and Dread Scott Decision both were very interesting cases. Their similarities zoomed to expose the preamble of the Constitution and make the authors of it think over what they meant by "all men are created equal." This question is still present today, are all men created equal? Or does it mean by men, the white Americans with European decent?
In 1971 in Mobile County Alabama the School Board created a state statute that set aside time at the beginning of each day for silent ’meditation’ (statute 6-1-20), and in 1981 they added another statute 16-1-20.1 which set aside a minute for ‘silent prayer’ as well. In addition to these, in 1982 the Mobile County School Board enacted statute 16-1-20.2, which specified a prayer that teachers could lead ‘willing’ students in “From henceforth, any teacher or professor in any public educational institution within the State of Alabama, recognizing that the Lord God is one, at the beginning of any homeroom or any class, may pray, may lead willing students in prayer, or may lead the willing students in the following prayer to God… “ (Jaffree By and Through Jaffree v. James). Ishmael Jaffree was the father of three students, Jamael Aakki Jaffree, Makeba Green, and Chioke Saleem Jaffree, who attended a school in Mobile County Alabama. Jaffree complained that his children had been pressured into participating in religious activities by their teachers and their peers, and that he had requested that these activities stopped. When the school did nothing about Jaffree’s complaints he filed an official complaint with the Mobile County School Board through the United States District Courts. The original complaint never mentioned the three state statutes that involved school prayer. However, on June 4, 1982 Jaffree changed his complaint. He now wanted to challenge the constitutionality of statutes 16-1-20, 16-1-20.1 and 16-1-20.2, and motioned for a preliminary injunction. The argument against these state laws was that they were an infringement of the Establishment Clause within the First Amendment of the Constitution, which states that Congr...
Established in 1968, the medical school at the University of California implemented a special admissions program to increase the representation of minorities in each entering class. There was one underlying problem with their special admissions program that was not addressed until 1973 when Allan Bakke submitted his application to the University of California.
Was Dred Scott a free man or a slave? The Dred Scott v. Sandford case is about a slave named Dred Scott from Missouri who sued for his freedom. His owner, John Emerson, had taken Scott along with him to Illinois which was one of the states that prohibited slavery. Scott’s owner later passed away after returning back to Missouri. After suits and counter suits the case eventually made it to the Supreme Court with a 7-2 decision. Chief Justice Taney spoke for the majority, when saying that Dred Scott could not sue because he was not a citizen, also that congress did not have the constitutional power to abolish slavery, and that the Missouri compromise was unconstitutional. The case is very important, because it had a lot
Separate but equal, judicial review, and the Miranda Rights are decisions made by the Supreme Court that have impacted the United States in history altering ways. Another notable decision was made in the Tinker v. Des Moines Case. Ultimately the Supreme Court decided that the students in the case should have their rights protected and that the school acted unconstitutionally. Justice Fortas delivered a compelling majority opinion. In the case of Tinker v Des Moines, the Supreme Court’s majority opinion was strongly supported with great reasoning but had weaknesses that could present future problems.
The movie “A Civil Action” released on January 8, 1999 provides viewers with an extraordinary story of the nightmare that occurred in Woburn Massachusetts in the late 1970’s. The people of this small town at the time had no idea what was going on until there were various cases of Leukemia in small children that ultimately resulted in the early passing of them. The people eventually had gone to find out that the drinking water in this small town was contaminated and there were many women that stepped in to get answers. This movie is a tremendously jaw dropping, eye opening account of a heartbreaking true story incident. There are various elements of negligence in this movie including, duty, legal cause, proximate cause and damages.
The Impact of the Dred Scott Case on the United States The Dred Scott Case had a huge impact on the United States as it is today. The Thirteenth and Fourteenth Amendments have called it the worst Supreme Court decision ever rendered and was later overturned. The Dred Scott Decision was a key case regarding the issue of slavery; the case started as a slave seeking his rightful freedom and mushroomed into a whole lot more. 65
The Dred Scott decision of the Supreme Court in March 1857 was one of the major steps
Also the prime suspect had other charges pending against him such as possession of illegal substances and the homeowner of the vacant crime scene said the man was a recovering addict. During the conversation with the officers Johnson refused to give up his DNA sample. The man profess he had not commit any murders and did not commit any crimes regarding the matter. Officers then compel him to give his DNA sample with a warrant compelling him to follow the order. Moreover, after the crime was committed it was discovered that Johnson try to sell one of the victims’ cell phone. He was trying to get rid of the evidence that could implement him on the crime. Witness came forward to verify this story that Johnson indeed try to sell the cell phone for cash. In addition, witness said that Johnson try to be the pimp of the victims that he was
Meurer, Michael. “Pharmacogenomics, Genetic Tests, and Patent-Based Incentives”, Boston University School of Law. Pages 1-8.
William Procter, Jr. is revered as the “Father of Pharmacy”. He worked in a drug store beginning at the age of fourteen. He spent his free time studying chemistry and pharmacy, and eventually opened his own pharmacy. In addition to being hired as a professor of pharmacy, he was also one of the founders of the
The case under analysis, Eli Lilly & Company, will be covering the positives and negatives with regards to the business situation and strategy of Eli Lilly. One of the major pharmaceutical and health care companies in its industry, Lilly focused its efforts on the areas of "drug research, development, and marketed to the following areas: neuroscience, endocrinology, oncology, cardiovascular disease, and women's health." Having made a strong comeback in the 1990's due to its remarkably successful antidepressant Prozac, was now facing a potential loss in profits with its patent soon to expire. The problem was not only the soon to expire patent on Prozac, but the fact that Prozac accounted for as much as 30% of total revenue was the reality Eli Lilly now faced. (Pearce & Robinson, 34-1)